Kornimate/medical-research-clean huggingface dataset:
comparison of n-butyl-cyanoacrylate and micro parti-cles effect in inducing liver hypertrophy after pve

Conditions: Portal Vein Embolization, Liver, Hypertrophy

Summary: the aim of this study is to compare hypertrophy of the flr after pve with microparticles to hypertrophy after pve with cyanoacrylate in a material large enough to answer the study question. in addition, other factors that may influence the degree of hypertrophy will be evaluated in a multivariable analysis. the hypothesis is: pve with cyanoacrylate is superior to pve with microparticles in terms of flr hy-pertrophy.

with expansion of indications for major liver surgery, portal vein embolization (pve) is increasingly used in order to induce hypertrophy of the future liver remnant (flr). de-spite vide variety of materials available to occlude the portal veins the most commonly used are cyanoacrylate and microparticles/spheres. earlier studies have failed to show superiority of one over the other in terms of hypertrophy of the flr while pve with cy-anoacrylate seems to be less time consuming. two small previous studies from single centers have shown greater growth by cyanoacrylate compared to particles (1) with 90 included patients and the second study with 34 included patients (2), but larger reviews have failed (3). cyanoacrylate might give a more robust flr hypertrophy (4) . the main problem in evaluating previous studies has been the large heterogeneity and the often poorly described study populations.

Eligibility criteria:
inclusion criteria: over 18 years old. planned for portal vein embolization. - exclusion criteria: -
computer-assisted fixation of trochanteric femur fractures

Conditions: Hip Fractures

Summary: the purpose of this study is to assess whether the stryker© adapt™ augmented-reality platform can assist surgeons in optimizing placement of the lag screw component of the stryker© gamma™ cephalomedullary nail.

this will be a prospective, randomized, single-blinded, controlled trial with two treatment cohorts. cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a stryker© gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw. cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a stryker© gamma™ cephalomedullary nail using the stryker© adapt™ platform to assist with insertion of the lag screw. patients will be blinded to treatment group allocation as will clinicians/researchers during data processing and analysis. the primary outcome will be tip-apex distance, as measured on anteroposterior and lateral hip radiographs. secondary outcomes will be position of the lag screw as described by cleveland et al, operative time, fluoroscopy time, and number of kirschner wire passes prior to final placement of the lag screw. additionally, evidence of lag screw cutout on hip radiographs, hip range of motion relative to the contralateral hip, overall mobility, social dependency, and pain level will be assessed at 3 month, 6 month, 1 year, and 2 year follow up visits.

Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and older with isolated closed peritrochanteric femur fractures who are candidates for surgical fixation with a cephalomedullary nail device exclusion criteria: 1. patients with open peritrochanteric femur fractures or multiple injuries (i.e., polytrauma) 2. patients with peritrochanteric femur fractures better treated with a device other than a cephalomedullary nail, as determined by the attending orthopedic surgeon 3. patients less than 18 years of age

Keywords: peritrochanteric femur fractures
effectiveness of triclosan coated sutures in preventing leg wound infection after coronary artery bypass surgery

Conditions: Complication of Coronary Artery Bypass Graft; Surgical Wound Infection

Summary: the purpose of this study is to assess whether triclosan-coated sutures reduces wound infections compared to regular non-coated sutures, after saphenous vein harvesting in cabg patients.


Eligibility criteria:
inclusion criteria: * 18 years of age or older with written informed consent * male and female subjects * subjects scheduled for an elective and urgent cabg surgery that includes saphenous vein harvesting. exclusion criteria: * known allergy or intolerance to triclosan * different surgical prophylactic antibiotic regimen than common in the department. * continuous preoperative and predicted postoperative antibiotic treatment.
68ga-fapi pet/mr for atherosclerosis

Conditions: Atherosclerosis

Summary: a thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. fibroblast activating protein (fap) is an active serine protease, which can degrade type i collagen, potentially thinning the fibrous cap. thus we speculate that atherosclerotic plaque could be imaged with 68ga-fapi pet/mr.

a thin-cap fibroatheroma with a large necrotic core and macrophage infiltration marks the vulnerable plaque. fibroblast activating protein (fap) is an active serine protease, which can degrade type i collagen, potentially thinning the fibrous cap. previous ex vivo analysis of human aortic atheromata revealed that fap was expressed in atherosclerotic plaques, and higher fap expression was detected in thin fibrous caps than thick caps. constitutive fap deletion in atherosclerosis-prone mice models could reduce plaque formation and improve plaque stability with increased fibrous cap thickness. thus we speculate that atherosclerotic plaque could be imaged with 68ga-fapi pet/mr.

Eligibility criteria:
inclusion criteria: * intracranial or carotid atherosclerosis patients * signed informed consent exclusion criteria: * pregnancy, breastfeeding * contradictions of mri * unstable vital signs

Keywords: atherosclerosis 68ga-fapi pet/mr
ides in asymptomatic antibody-mediated thrombotic thrombocytopenic purpura (ttp) patients

Conditions: Purpura, Thrombotic Thrombocytopenic

Summary: the main purpose of this study is to evaluate safety and tolerability in patients diagnosed with asymptomatic antibody-mediated ttp with low adamts13 activity after receiving single intravenous dose of ides.

immunoglobulin g-degrading enzyme of streptococcus pyogenes (ides) is an igg specific endopeptidase which cleaves igg molecules and efficiently neutralizes fc-mediated activities. ides-mediated igg degradation constitutes a novel therapeutic principle for the treatment of igg-driven human diseases. in addition to assessing the safety and tolerability of ides the study will also assess the efficacy of ides to significantly increase the adamts13 activity and decrease the anti-adamts13 antibody levels in patients diagnosed with asymptomatic antibody-mediated ttp with low adamts13 activity.

Eligibility criteria:
inclusion criteria: * age 18 years or above * diagnosed with acquired ttp with adamts13 levels of ≤ 10 % in clinical remission and with measurable or previously confirmed adamts13 antibodies exclusion criteria: * prior malignancy within 5 years * test positive for serum hepatitis b surface antigen, hepatitis c antibody and human immunodeficiency virus (hiv) * ongoing infectious disease including p-crp \>10 * test positive for ige antibodies against ides * secondary cause of ttp * rituximab treatment or other antibody-based therapy within 7 days prior to ides dosing * treatment with investigational medicinal product within the last 12 weeks proceeding screening * severe other conditions requiring treatment and close monitoring, e.g. cardiac failure \> nyha (new york heart association) grade 3, unstable coronary disease or oxygen dependent copd * history of any other clinically significant disease or disorder which may either put the patient at increased risk because of participation in the study, or influence the results or the patient's ability to participate in the study * hypogammaglobulinemia defined as any values of p-total igg less than 3 g/l * history of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to ides (e. g. streptokinase and/or staphylokinase) * substance abuse or other concurrent medical condition that could confound study interpretation or affect the patient's ability to tolerate or complete the study * breast feeding women or women with a positive pregnancy test * previously received ides treatment

Keywords: asymptomatic antibody-mediated ttp
physical training program in patients hospitalized for community-acquired pneumonia

Conditions: Pneumonia

Summary: hospitalized patients with community-acquired pneumonia (cap) have reduced functional capacity, peripheral muscle strength and quality of life. despite the high incidence and severity has not yet been demonstrated whether a physical training program can change these outcomes. objectives: to evaluate the effects of an exercise training program in patients hospitalized for cap, to compare this effects with traditional physical therapy and assess whether the inflammatory markers correlate with the functional status of the patient and type of treatment. methods: a controlled, prospective, randomized clinical trial. patients hospitalized for cap, adults, conscious, hemodynamically stable and independent to walk will be studied. in the first day, a medical history, measured dyspnea, incremental shuttle walk test, glittre test, measurement of peripheral muscle strength, spirometry, and the application of quality of life questionnaire shor form 36 will be held. the measurement of inflammatory markers (c-reactive protein and tumor necrosis factor) will also be held. patients will be randomized into two groups: one will perform a program of physical training (stretching, active resistance exercises and aerobic exercises) and the other group held the traditional physical therapy (bronchial hygiene, breathing exercises and walking) for eight days. on the tenth day the same assessment will be carried out initially described.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of pneumonia * must be able to walk * time less than 48 hours of hospitalization * age above 18 years * conscious and oriented * hemodynamically stable exclusion criteria: * patients with other respiratory diseases * osteoarticular or cognitive disorders * patients who refuse to participate or complete the procedures
comparison of psyllium and microcrystalline cellulose on glycemic measures in subjects with impaired fasting glucose

Conditions: Impaired Fasting Glucose

Summary: the purpose of this study is to compare the effects of 2 types of dietary fiber, psyllium and microcrystalline cellulose (mcc), on glycemic measures in subjects with impaired fasting glucose.

this study will be conducted at a single study center. approximately 40 subjects with pre-type 2 diabetes will be enrolled and randomized in this study. this 22-week study consists of 3 periods: an 8-week treatment period (visits 2-4), a 6-week washout period, and an 8-week treatment period (visits 5-7).

Eligibility criteria:
inclusion criteria: * be male or female, * at least 18 years of age * in generally good health for the pre-type 2 diabetes population; * if female, be postmenopausal or if of child-bearing capacity agree to use an adequate form of contraception * have not used any psyllium containing products within the past 3 months; * be willing to refrain from taking any psyllium containing products during the study; * be willing to maintain a lifestyle habits for the duration of the study; * have a fasting serum glucose of 110 - 125 mg/dl exclusion criteria: * if female, are pregnant or nursing (lactating); * have a history of diabetes (diagnosis) or is currently taking medications for diabetes * participated in a clinical drug study or used investigational drug during the previous 30 days; * have symptoms and signs suggestive of significant underlying disease, or acute onset of new symptoms and signs of major organ disease, that could become unstable during the trial requiring urgent medical intervention * have evidence of or treatment history of malignancy within the previous 5 years; * currently alcohol dependent; * used anti-psychotics in the previous 3 months; * used systemic steroidal agents within the last 30 days; * had used oral or systemic antibiotics or any over-the-counter (otc) bactericidal medication (eg, bismuth salts) within the last 30 days; * has been taking any medication that may affect blood glucose or gi motility (eg, calcium channel blockers, beta blockers, antimuscarinics, salicylates etc.) for less than 30 days or 5 times the half life of the drug (need to be stable on the medication); * have evidence of immunodeficiency including subjects currently taking systemic corticosteroids or immunosuppressive drugs * have a major psychiatric disorder, including major depression, psychoses, alcohol or substance abuse within the past 2 years; * has a known sensitivity or allergy to any components of study products, including psyllium and aspartame (see section 3.5.3); * were previously screened (ie, visit 1 procedures) for participation in this study and failed to meet entry criteria; * have difficulty swallowing
an open-label, dose escalation study to investigate the safety, pharmacokinetics, pharmacodynamics and clinical activity of gsk3326595 in participants with solid tumors and non-hodgkin's lymphoma

Conditions: Neoplasms

Summary: this first time in human (ftih) open-label, dose escalation study will assess the safety, pharmacokinetics (pk), pharmacodynamics (pd), and preliminary clinical activity of gsk3326595 in participants with advanced or recurrent solid tumors, as well as clinical activity in participants with a subset of solid tumors and non-hodgkin's lymphoma (nhl).


Eligibility criteria:
inclusion criteria: * males and females greater than or equal to (\>=)18 years of age (at the time consent is obtained) * eastern cooperative oncology group (ecog) performance status score of 0 or 1 or 2 * diagnosis of non-resectable or metastatic solid malignancy (as defined in the protocol) or nhl * presence of evaluable disease * adequate organ function (as defined in the protocol) * reproductive criteria (as defined in the protocol). exclusion criteria: * malignancy attributed to prior solid organ transplant * leptomeningeal disease, spinal cord compression, or brain metastases that require immediate central nervous system (cns)-specific treatment in the opinion of the investigator (for example \[e.g.\], for symptomatic disease) * history of a second malignancy, excluding non-melanoma skin cell cancer within the last three years * evidence of severe or uncontrolled systemic diseases, or serious and/or pre-existing medical or other condition that could interfere with participant's safety, obtaining informed consent or compliance to the study procedures, in the opinion of the investigator * any clinically significant gastrointestinal (gi) abnormalities that may alter absorption such as malabsorption syndrome or major resection of the stomach and/or bowels. * select cardiac abnormalities (as defined in the protocol) * history of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation. * history of optic nerve neuropathy or neuritis.

Keywords: gsk3326595 solid tumor non-hodgkin's lymphoma (nhl) urinary tract cancer dose escalation adenoid cystic carcinoma (acc) non small-cell lung cancer (nsclc) squamous cell carcinoma of the head and neck (hnscc) melanoma
influenza vaccine postpartum questionnaire

Conditions: Influenza; Vaccine; Pregnancy

Summary: the purpose of this trial is to assess the knowledge and attitudes of post-partum women regarding influenza and the use of the influenza vaccine in pregnancy.

women on our post-partum floor will be approached to complete a questionnaire which will assess their knowledge and attitudes regarding influenza and the use of the influenza vaccine in pregnancy. the study will take place over a 2-month period during influenza season, and at the time when the influenza vaccine becomes available.

Eligibility criteria:
inclusion criteria: * women admitted to the postpartum floor during the study period exclusion criteria: * inability to read or understand english

Keywords: influenza influenza vaccine pregnancy
pet-ct after nellix implantation

Conditions: Aortic Aneurysm; Endovascular Repair

Summary: to determine fdg uptake following uncomplicated evar using the nellix endoprosthesis. does uncomplicated evar using the nellix endoprosthesis result in increased fdg uptake and false positive pet imaging?

one of the most devastating complications following endovascular aneurysm repair (evar) is infection of the used endoprosthesis. because of the high mortality of secondary surgery following infection, patients with a possible endoprosthesis infection are treated using broadspectrum antibiotics during months, years or even life-long. unfortunately, the diagnosis of an endoprosthesis infection is difficult and based upon clinical suspicion and non-specific symptoms (e.g. fever and weigth loss) only. fluorodeoxyglucose positron emission tomography (fdg-pet) is often used as a diagnostic tool to identify infection following evar. like infection, sterile physiologic inflammation following evar is also associated with increased metabolism and fdg uptake. this could result in (false-)positive pet imaging resulting in diagnostic errors and antibiotic overuse. the nellix endoprosthesis is a relatively new device used for evar. in present literature there is no data on the degree of physiologic inflammation following implantation of a nellix device and the value of postoperative fdg-pet imaging to detect infection is not known. this makes the diagnosis of infection following nellix implantation extremely difficult. this pilot is designed to determine physiologic fdg uptake following uncomplicated evar using the nellix endoprosthesis.

Eligibility criteria:
inclusion criteria: * patients treated with nellix endoprosthesis exclusion criteria: * diabetes mellitus (type 1 and type 2) * current known inflammation or malignancy
response of cardiac resynchronization therapy optimization with ventricle to ventricle timing in heart failure patients

Conditions: Heart Failure

Summary: the purpose of the study is to evaluate the benefit of interventricular (v-v) delay optimization in reducing the non-responder rate in patients with cardiac resynchronization defibrillator (crt-d) devices. the primary endpoint of this study is crt responder rate. for patients enrolled with new crt-d systems, patients are considered non-responders if both of the following requirements are fulfilled: * \< 10% improvement in 6-minute hall walk, and * no class improvement or worsening in new york heart association (nyha) scale. for those receiving crt-d devices as replacements of older crt-d systems, patients are considered non-responders if both of the following requirements are fulfilled: * \> 1 heart failure (hf) related hospitalization, and * no class improvement or worsening in nyha scale.

study methods * this is a prospective, randomized (simultaneous biventricular (biv) pacing vs. sequential biv pacing) study. * any patient that receives an fda approved st. jude medical (sjm) crt-d with v-v timing is eligible for enrollment. * at 3 months post enrollment (or at implant for crt-d replacements), patients screened as non-responders are randomized to either simultaneous or sequential biv pacing. patients requiring a replacement crt-d device that are identified as non-responders to crt are enrolled at the screening/randomization visit. * patients are followed for a period of 6 months post randomization: * enrollment (1 week pre crt-d implant to \< 2 weeks post crt-d implant) * screening/randomization visit (3 months post enrollment) * follow-up visit (6 months post randomization) * total # of centers - 80 centers * sample size - 800 patients screened for crt non-responders

Eligibility criteria:
inclusion criteria: * patient has a standard indication for a crt-d. * patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath. * patient is geographically stable and willing to comply with the required follow-up schedule. * prior to 1 month of randomization, patient's hf medications are maintained stable and remain stable throughout the study. * patients requiring a crt-d replacement must comply with both of the following: * \> 1 hf related hospitalization * no class improvement or worsening in nyha scale exclusion criteria: * patient's life expectancy is less than 12 months. * patient has had cardiac surgery within 6 months of enrollment. * patient has an epicardial ventricular lead system. * patient is less than 18 years old. * patient is pregnant.
narrow implants vs standard implants with simultaneous gbr

Conditions: Narrow Implant; Dental Implant; Bone Regeneration

Summary: ndi represent an advisable treatment option when the mesio-distal space is compromised. in a recent retrospective study with a follow-up of 8 years in which they wanted to evaluate the long-term survival, complications, peri-implant conditions, marginal bone loss, and patient satisfaction of fixed dental prostheses supported by ndi in the posterior area. they observe a survival rate of 97% and absence of prosthetic complications after the study period time. more recently, souza et al. performed a prospective randomized split mouth study with 3 years follow-up with the aim of comparing marginal bone level, implant survival and success rates and prosthesis success rates of ndi and sdi placed in the posterior area of the mandible to support single prosthesis. they observed an implant survival rate of 100% for both groups at 1 and 3 years. the prosthesis success rate at 1 and 3 years was of 95.4% and 100%, respectively. ndi present a high survival rate on the evaluated studies. therefore, the aim of the first study is to compare the patient related outcomes, implants and prostheses success and survival rates of pure titanium ndi versus sdi with simultaneous bone regeneration in narrow alveolar ridges at posterior areas of the maxilla and the mandible.


Eligibility criteria:
inclusion criteria: patients: * 18 years old * healthy periodontal status (absence of generalized probing pocket depth (ppd) \<4mm) * oral hygiene levels (fmps \<20 and fmbs \<20) site: * ridge width of \>5mm and \<6.5mm and minimum bone height of 10mm prior evaluation on a cbct scan * presence of antagonistic natural tooth or fixed prosthetic restoration * presence of adjacent teeth * one maxillary or mandibular premolars * minimum of 3mm of keratinized tissue over the bone crest (20) * bone regeneration within the limits of the prosthetic restoration. implants: * unitary prosthesis * screwed retained restorations exclusion criteria: patients * presence of active chronic or aggressive periodontal disease * presence of systemic disease which contraindicate surgery (patients with an asa ≥ 3) * drugs or medications which may alter the results (chronic intake of analgesic medication) * smokers (\>10cig/day) * pregnant women * history of head and neck radiotherapy. site * anterior area (from 1.3 to 2.3 and from 3.3 to 4.3) and molar area * previous guided bone regeneration * location where there is not sufficient restorative space (mesio-distally \<8mm for every restoration unit and \<5mm from the bone crest to the antagonist) * implant dehiscence of more than 2/3 of the implant. implant * implants which cannot be restored with a screwed restoration * implants which doesn't reach a manual implant stability * implants which after placement doesn't reach a favourable position according to the restoration.

Keywords: narrow implant